Throughout my life I've been to countless sporting
events--from local soccer matches my kids have been involved in up to
major league events in almost every sport. If there is one thing I have
learned over the years it's that you can't win an argument
with a referee. Whether it's an overzealous parent on the sideline,
a student/athlete on a high school field or a professional athlete in a
big city stadium--arguing with a referee or an umpire will get you no
where. Yet people continue to do so--and frankly I don't understand
why. During a sporting event--the referee is the LAW out there on the
playing field--and all of his or her decisions are final--so why bother
fighting city hall? And yet many people continue to try--only to find
themselves being thrown out of a game; or in the case of an overzealous
parent--asked to leave the sideline.

A similar situation came to light recently when a major
pharmaceutical manufacturer was warned by the FDA that they were in
violation of the law by marketing over-the-counter pain relievers with
unproven health claims.

The agency allows traditional pain relievers to be sold
over-the-counter without review, as long as they include standard
directions and labeling for consumers. But the FDA said the products
from the company in question overstepped those regulations by claiming
that the added ingredients in each medicine help fight specific
diseases.

In general, the FDA discourages firms from packaging drugs with
dietary supplements because it gives the impression both have been
evaluated by the FDA, when in fact, the agency only regulates drugs.

What were they thinking? Going back to my sport analogy--the FDA is
the referee and they make the rules--so what did this company hope to
accomplish? In this case you can't fight city hall or the FDA and
the repercussions are more severe than a simple red card.

Have a comment or question about Pharmaceutical Processing? My
E-mail is: mike.auerbach@advantagemedia.com

* Michael Auerbach, Editor in Chief

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